EUNew treatments and approvals
EU approves mirdametinib for NF1-related plexiform neurofibromas that cannot be removed by surgery
A decision by a medicines regulator (FDA, European Commission, etc.). The regulator has reviewed the clinical studies behind the drug. For accelerated or conditional approvals, the lasting benefit is still being confirmed.
The European Commission granted conditional approval to mirdametinib for NF1-related plexiform neurofibromas. The drug is for tumors that cause symptoms and cannot be removed by surgery. It can be used in children aged two years and older and in adults. The tumor shrank by at least one-fifth in 52% of children and 41% of adults. The study had no comparison group.
What does it mean for patients and families?
With conditional approval, additional data are submitted later. Access in Türkiye depends on TİTCK (Turkish Medicines and Medical Devices Agency) and SGK (Social Security Institution) processes.
Source
Avrupa İlaç Ajansı (EMA) · source page
The source page was opened and read on October 7, 2026. Summary prepared by the Doktorclub editorial team and translated from Turkish; it has not yet been reviewed by a physician (a scientific board is being set up).
This page is translated from the Turkish original.
Related disease: Neurofibromatosis type 1 (NF1)
This page reports a development; it is not a treatment recommendation. Your doctor decides whether a treatment is right for you.